Qtech-Sol Professional Development Center

Drug Safety-Pharmacovigilance Data Management (DSPM)

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DSPM

Drug Safety-Pharmacovigilance Data Management (DSPM)

3 Students Enrolled
8 Weeks / 200 Hours

A Drug Safety-Pharmacovigilance Data and Safety Monitoring and report submissions to Authorities. Responsible for the monitoring, data collection and Analysis and reporting of drug safety information for compliance with drug safety regulations per international markets.
Data Management.

Our Programs are delivered in 3 Different ways for convenience of student:
• Self-Paced Individual Program (SIP)
– Skill and Job Oriented Certificate programs, delivered as Self-Paced Online with project solutions
• Self-Paced Blended Program (SBP)
– Skill and Job Oriented Certificate programs, delivered as Self-Paced Online with project solutions. Support thru Email and Phone for queries. Student participates in 7 days Post Training Assistance program for Resume preperation
• Self-Paced Package Program (SPP)
– Skill and Job Oriented Certificate programs, delivered as Self-Paced Online with project solutions. Support thru Email and Phone for queries. Student participates in 15 days Post Training Assistance program for Resume preperation, Interview Narratives and Mock session. Obtains Job refferal and leads for application with clients and vendors

Lessons: 33 Lessons Duration: 08 Weeks / 200 Hours Language: English
Admission Requirements:

Recommended: A Bachelor or Master’s degree in medicine, Nursing (RN), Pharm D, Public Health, Pharmaceutical and Industrial Chemistry, Industrial Pharmacy, Industrial Chemistry.

Scholarship:

Institutional Scholarship / Promotion is available for selected on tuition. We review your education background, certifications, and prior experiences (if applicable), to evaluate your eligibility. Qualified student will be provided with the promo code for scholarship on Tuition.
Please Email your resume to Human Resources hrs@qtech-solutions.com to check on your eligibility. We will contact you. Q-tech’s objective is to provide you the right career pathway and advancement required to meet your career goals.

Learning Outcomes:

The Benefit Student Gains

1) Upgrading the Knowledge required.
2) Better Resume Placement for promising jobs.
3) Low Investment, high learnings
4) Learn from Anywhere, Anytime at your pace.
5) Job and Title Based Tasks as followed and Practiced in industry
6) Applying Concept into Real-time (Policies, governance and tools)
7) Work on Role Based Tasks followed and Practiced in industry
8) Mocks and Narratives for Client Discussions
9) Readiness to work with limited support

Career Pathways

Our objective is to help students to meet the following career pathways. Typical Drug Safety / Pharmacovigilance Associate (DSA) Job Titles the candidates can apply after this training program are

DRUG SAFETY MANAGER / PHARMACOVIGILANCE SPECIALIST JOB TITLES
Manager, Drug Safety and PharmacovigilanceManager, Drug Safety Science
Medical Operations LeaderLocal Safety Manager (LSM)
Drug Safety PhysicianTeam Lead Quality & Safety
Therapeutic Area LeadSafety Review Specialist – Literature team
Medical ReviewerMedical Safety Manager

 

  • Curriculum Overview

    Designed by industry experts for students and young professionals. The training program provides in depth knowledge of roles and responsibilities of Drug Safety / Pharmacovigilance Specialist including theoretical aspect of the field and exposure to variety exercises based on industry requirements.

    DRUG SAFETY-PHARMACOVIGILANCE DATA MANAGEMENT

    ADVANCED DRUG SAFETY TOPICS

    1. Medical Record Extraction

    2. Adverse Events Case Processing

    3. CIOMS Line Listing

    4. Case processing and FDA Reporting

    for Medical Devices

    5. Revision of SOP Quality Control

    Procedure

    6. SAE Reconciliation

    7. PSUR - Periodic Safety Update

    Reporting

    8. Triage

    9. Data Entry

    10. Signal Detection

    11. Labeling Edit check

    12. Quality Control Procedure

    13. Resolution of queries of pending cases

    14. SUSAR - Suspected Unexpected

    Serious Adverse Reaction

    DRUG SAFETY DATA MANAGEMENT

    15. Introduction to MedDRA

    16. MedDRA Coding Guidelines- Modules 1 thru 4

    17. AE Causality assessments

    18. Introduction to Risk Management Plan (RMP)

    19. Introduction to Risk Management Plan (REMS)

    20. Argus Safety End-User Training Modules 1 thru 6

    21. Product Technical / Quality Complaints (PTC / PQC)

    22. Corrective and Preventative Actions (CAPAs)

    23. Overview of Aggregate Reporting (PSUR/ PBRER)

    24. Overview of Aggregate Reporting - PRAC / DSUR

    EXERCISES

    1. Medical Record Extraction.

    2. Adverse Events Case Processing

    3. CIOMS Line Listing

    4. Case processing and FDA Reporting for Medical Devices

    5. Revision of SOP

    6. Quality Control Procedure

    7. SAE Reconciliation

    8. Triage

    9. Data Entry

    10. Signal Detection

    11. Labeling Edit check

    12. Quality Control Procedure

    13. Resolution of queries of pending cases

    14. SUSAR - Suspected Unexpected Serious Adverse Reaction

Instructor

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5.00 average based on 3 ratings

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Reviews

  • Maureen D

    Ramya I (New Jersey)

    The program gave me an in-depth understanding of the role of a DSA in Clinical Research and Pharmacovigilance department. With the practical examples and lectures from professionals I gained a clear understanding about the practical applications needed for work. Very good course work!
  • Gamal A

    Kinjal C (Virginia)

    The best part about DSA training is presentations which clearly mention the important and key points that are helpful for building basics in the subject. I found the exercises helpful in understanding the format on how to fill the forms and analyzing the data which will be useful in real time for me.
  • Sangeetha T

    Latha T. (New Jersey

    I am a Medical Science graduate. This Certificate training helped me to understand the Job related work process better. The Drug Safety Associate training program offered at qtech is very useful for beginners, I liked it and highly recommend others. Currently I am enrolled into Internship program to meet my career goals.

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